Nexavar Data To Be Presented at 46th American Society of Clinical Oncology Annual Meeting
Berlin, May 21, 2010 - Bayer HealthCare Pharmaceuticals, Inc. and Onyx Pharmaceuticals, Inc. today announced that more than 70 studies evaluating the use of Nexavar® (sorafenib) tablets will be presented at the 2010 American Society of Clinical Oncology (ASCO) annual meeting, June 4-8, 2010, in Chicago, IL.
"Bayer and Onyx are encouraged by the number and breadth of studies involving Nexavar that are being presented at ASCO," said Dimitris Voliotis, vice president, Global Clinical Development Oncology, Bayer HealthCare. "We have built a strong foundation with Nexavar in the treatment of patients with unresectable liver cancer and advanced kidney cancer and are committed to continuing research across tumor types and in a variety of treatment settings to determine the full potential of this therapy for cancer patients."
Nexavar data highlights include:
Hepatocellular Carcinoma (HCC) • Sorafenib or Placebo in Combination with Transarterial Chemoembolization (TACE) for Intermediate-Stage Hepatocellular Carcinoma (SPACE) o Professor Riccardo Lencioni, Division of Diagnostic and Interventional Radiology, Cisanello University Hospital, Pisa, Italy o Abstract TPS178, Trials in Progress Poster Session, Clinical Trials Special Session o Monday, June 7, 2010, 8:00 a.m.-12:00 p.m., S Hall A2
• Efficacy and Safety of Sorafenib in Patients with Advanced Hepatocellular Carcinoma; Subgroup Analysis of the SHARP Trial by Baseline Transaminase (ALT/AST)/? alpha-Fetoprotein (AFP) and Bilirubin Levels o Jean-Luc Raoul, M.D., PhD, Centre Eugene Marquis, Rennes, France o Abstract 4051, General Poster Session, Gastrointestinal (Noncolorectal) Cancer Track o Sunday, June 6, 2010, 2:00-6:00 p.m., S Hall A2
Renal Cell Carcinoma (RCC) • Long-term Sorafenib Safety Profile in More Than 700 Patients with Renal-Cell Carcinoma Treated for 12 to 42 Months o Thomas E. Hutson, DO, PharmD, FACP Texas Oncology, PA, Baylor Sammons Cancer Center, Baylor University Medical Center Dallas, Texas o Abstract 4614, General Poster Session, Genitourinary Cancer Track o Monday, June 7, 2010, 1:00-5:00 p.m., S Hall A2
Lung Cancer • Sorafenib Treatment Efficacy and KRAS Biomarker Status in the Biomarker-Integrated Approaches of Targeted Therapy for Lung Cancer Elimination (BATTLE) trial. o Roy Herbst, M.D., Ph.D., Department of Thoracic/Head and Neck Medical Oncology, MD Anderson Cancer Center, Houston, Texas o Abstract 7609, General Poster Session, Lung Cancer - Metastatic Track o Sunday, June 6, 2010, 8:00 a.m.-12:00 p.m., S Hall A2
Breast Cancer • Multivariate Analysis (MVA) of Progression-Free Survival (PFS) in 2 Phase 2b, Multinational, Double-Blind, Randomized, Placebo-Controlled Trials Evaluating Sorafenib Plus Standard Chemotherapy in Patients with HER-2 Negative Locally advanced or Metastatic Breast Cancer. o William John Gradishar, M.D., Northwestern University Feinberg School of Medicine, Chicago, Illinois o Abstract 1073, General Poster Session, Breast Cancer Track o Saturday, June 5, 2010, 2:00-6:00 p.m., S Hall A2
• A Regional Subgroup Analysis of a Multinational, Double-Blind, Randomized, Placebo Controlled, Phase 2b Study Evaluating Sorafenib (SOR) with Paclitaxel (PAC) in Patients (pts) with Advanced Breast Cancer (BC). o Tarini Prasad Sahoo, M.D., Jawaharlal Nehru Cancer Hospital & Research Centre, Bhopal, India o Abstract 1114, General Poster Session, Breast Cancer Track o Saturday, June 5, 2010, 2:00-6:00 p.m., S Hall A2
• Management of Hand-Foot Skin Reaction (HFSR)/Hand-Foot Syndrome (HFS) in SOLTI-0701: A Double-Blind, Randomized Phase 2b Study Comparing Sorafenib vs Placebo in Combination with Capecitabine in Patients with Advanced Breast Cancer. o Patricia Gomez, M.D., Breast Cancer Center, Vall d’Hebron University Hospital, Barcelona, Spain o Abstract 1083, General Poster Session, Breast Cancer Track o Saturday, June 5, 2010, 2:00-6:00 p.m., S Hall A2
"With more than 70 investigator and company sponsored studies being presented at ASCO, we look forward to continuing our work with investigators to understand how Nexavar may fit into other areas of the therapeutic landscape, particularly with respect to how biomarkers status may guide selection of therapy, which is a step toward personalized medicine," said Ted W. Love, M.D., Executive Vice President and Head of Research and Development at Onyx Pharmaceuticals.
About Nexavar® Nexavar®, an oral anti-cancer therapy, is currently approved in more than 90 countries for liver cancer and for the treatment of patients with advanced kidney cancer. In Europe, Nexavar is approved for the treatment of hepatocellular carcinoma and for the treatment of patients with advanced renal cell carcinoma (RCC) who have failed prior interferon-alpha or interleukin-2 based therapy or are considered unsuitable for such therapy.
Nexavar targets both the tumor cell and tumor vasculature. In preclinical studies, Nexavar has been shown to target members of two classes of kinases known to be involved in both cell proliferation (growth) and angiogenesis (blood supply) - two important processes that enable cancer growth. These kinases included Raf kinase, VEGFR-1, VEGFR-2, VEGFR-3, PDGFR-B, KIT, FLT-3 and RET.
Nexavar, which is co-developed by Bayer Healthcare and Onyx Pharmaceuticals, is being evaluated by the companies, international study groups, government agencies and individual investigators as a single agent or as a combination treatment in a wide range of cancers, including lung, thyroid, breast, ovarian, and colorectal cancer and as an adjuvant therapy for liver and kidney cancer.
About Onyx Pharmaceuticals, Inc. Onyx Pharmaceuticals, Inc. is a biopharmaceutical company committed to improving the lives of people with cancer. The company, in collaboration with Bayer HealthCare Pharmaceuticals, Inc., is developing and marketing Nexavar® (sorafenib) tablets, a small molecule drug.
About Bayer HealthCare The Bayer Group is a global enterprise with core competencies in the fields of healthcare, nutrition and high-tech materials. Bayer HealthCare, a subsidiary of Bayer AG, is one of the world’s leading, innovative companies in the healthcare and medical products industry and is based in Leverkusen, Germany. The company combines the global activities of the Animal Health, Bayer Schering Pharma, Consumer Care and Medical Care divisions. Bayer HealthCare’s aim is to discover, manufacture and market products that will improve human and animal health worldwide.
About Bayer Schering Pharma Bayer Schering Pharma is a worldwide leading specialty pharmaceutical company. Its research and business activities are focused on the following areas: Diagnostic Imaging, General Medicine, Specialty Medicine and Women's Healthcare. With innovative products, Bayer Schering Pharma aims for leading positions in specialized markets worldwide. Using new ideas, Bayer Schering Pharma aims to make a contribution to medical progress and strives to improve the quality of life.
Forward-Looking Statements This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer Group or subgroup management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.
Posted: May 2010